A Study to Compare Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis (RA) Who Are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 192
Summary
- Conditions
- Rheumatoid Arthritis
- Type
- Interventional
- Phase
- Phase 2Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This study consisted of a 35-day screening period; a 12-week randomized, double-blind, parallel-group, placebo-controlled treatment period (Period 1); a 248-week blinded long-term extension period (Period 2); and a 30-day follow-up period (call or visit). Participants who met eligibility criteria we...
This study consisted of a 35-day screening period; a 12-week randomized, double-blind, parallel-group, placebo-controlled treatment period (Period 1); a 248-week blinded long-term extension period (Period 2); and a 30-day follow-up period (call or visit). Participants who met eligibility criteria were randomized in a 3:3:3:1:1:1 ratio to one of six treatment groups: Group 1: Upadacitinib 7.5 mg QD (Period 1) ? upadacitinib 7.5 mg QD (Period 2) Group 2: Upadacitinib 15 mg QD (Period 1) ? upadacitinib 15 mg QD (Period 2) Group 3: Upadacitinib 30 mg QD (Period 1) ? upadacitinib 30 mg QD (Period 2) Group 4: Placebo (Period 1) ? upadacitinib 7.5 mg QD (Period 2) Group 5: Placebo (Period 1) ? upadacitinib 15 mg QD (Period 2) Group 6: Placebo (Period 1) ? upadacitinib 30 mg QD (Period 2)
Tracking Information
- NCT #
- NCT02720523
- Collaborators
- Not Provided
- Investigators
- Study Director: AbbVie Inc. AbbVie
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